THEORETICAL FOUNDATIONS FOR THE DEVELOPMENT OF RULES FOR THE STORAGE OF MEDICINES IN THE REPUBLIC OF TAJIKISTAN

Abstract

Relevance: Currently, the Republic of Tajikistan is at the stage of formation of national pharmaceutical practice and standardization of pharmaceutical services, including regulation of drug storage issues. Considering that the Republic of Tajikistan is a member of the World Health Organization and an eventual participant of the Eurasian Economic Union, it is advisable to consider international approaches to the organization of storage of medicines recommended by WHO and the EAEU in order to develop national storage rules in the Republic of Tajikistan. Objective: To study international requirements for the organization of storage of medicines and to form a theoretical basis for further development of Rules for the storage of medicines in the Republic of Tajikistan. Materials and methods: Through content analysis, WHO recommendations, regulatory legal documents of the EAEU and national regulations regarding the organization of drug storage were studied. The concept of forming a theoretical basis for the development of rules for the storage of medicines in the Republic of Tajikistan is illustrated by the method of grouping and graphical analysis. With the use of comparative, structural and logical analyses, the key principles of the formation of existing international and national requirements for the organization of drug storage are summarized and theoretical provisions for the development of Rules for the storage of drugs in the Republic of Tajikistan are substantiated. Results: The WHO Guidelines on Good Storage Practices for Pharmaceutical Products (GSP) were studied. The analysis showed that the GSP contains a description of the special measures necessary for the proper storage and transportation of pharmaceutical products. It is established that the basic principle of GSP formation can be defined as "act by the rules", i.e. the semantic emphasis of the document is shifted towards pedantic adherence to the requirements established in it, excludes the initiative of the participants in the process and indicates the need to comply with national and regional requirements regarding the storage of medicines. The requirements for the organization of storage of medicines in the EAEU countries have been studied. It is noted that the main principle of ensuring the quality of medicines in the EAEU countries is a risk-based approach, which can be defined as "acting ahead of the curve". The analysis of national requirements for the organization of storage of medicines in the EAEU countries for compliance with the established principles of the organization of storage of medicines in the international space. The main approaches to the organization of storage of medicines in the EAEU countries are defined. Conclusion: Based on the communication of the research results, the concept of effective organization of drug storage is formulated and the necessity of using the proposed methodology as a theoretical basis for the development of national rules for drug storage in the Republic of Tajikistan is substantiated.